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Prozac® (fluoxetine)

Prozac (fluoxetine hydrochloride) is an oral medication used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorder. Manufactured by Eli Lilly and Company, Prozac is in a class of antidepressant medications called Selective Serotonin Reuptake Inhibitors (SSRIs) that affect chemical messengers within the brain, or neurotransmitters. Many experts believe that an imbalance in neurotransmitters is the cause of depression.

Why is Prozac prescribed?

Prozac is prescribed to treat depression and obsessive compulsive disorders by affecting the release of serotonin in the brain.

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What are the FDA approved uses for Prozac?

Prozac was approved by the FDA in 1987 for the treatment of depression, obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorder.

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What are the side effects of Prozac?

Side effects commonly associated with Prozac include nausea, difficulty sleeping, anxiety, nervousness and sleepiness.

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Prozac warnings and alerts

In 2005, the FDA issued a black box warning to be included on the labeling of Prozac that recommends close observation of adult and pediatric patients treated with Prozac for worsening depression or the emergence of suicidality. The FDA announced that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior.

In 2006, the FDA announced the results of a study looking at the use of Prozac during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN). Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies.

Also in 2006, the FDA issued an alert stating that a life-threatening condition called Serotonin Syndrome can occur when medicines called Serotonin and Norepinephrine Reuptake Inhibitors (such as Prozac) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans) are taken together. Serotonin Syndrome is a condition caused by an excess of serotonin in the brain, and the effects may progress from headaches, dizziness and vomiting, to coma and death.

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Prozac drug contradictions

Prozac is contraindicated in patients who take MAO inhibitor medications. MAO inhibitors should not be taken for at least five weeks after discontinuing Prozac. Serious and fatal cases of Serotonin Syndrome have been reported in patients treated with Prozac and a MAOI in close temporal proximity.

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Prozac FAQs

Who should NOT take Prozac?

You should not use Prozac if you are taking another drug to treat depression. You should also not use Prozac in conjunction with a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 5 weeks. Taking Prozac and an MAOI within a close period of time can result in serious (and sometimes fatal) reactions including high body temperature, coma and seizures/convulsions.

What are all the health risks associated with Prozac?

Health risks associated with Prozac use include:

  • Possible development of Serotonin Syndrome when Prozac is taken with triptan medicines
  • Infant persistent pulmonary hypertension
  • Suicidal thoughts or actions
  • Possible allergic reactions, such as skin rash, hives, breathing problems, or swelling of the tongue, lips, or throat
  • Bleeding Problems
  • Mania (becoming unusually hyperactive, excitable, or elated)
  • Seizures (convulsions), even if not taken within a close period of time with a MAOI
  • Problems if you are or may become pregnant; babies delivered to mothers taking Prozac late in pregnancy have developed problems, such as difficulty breathing and feeding
  • Weight loss
  • Sexual Problems, including impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire)

Are there withdrawal side effects from stopping the use of Prozac?

If Prozac is discontinued abruptly, withdrawal symptoms can include dizziness, headache, nausea, changes in mood, or changes in the sense of smell, taste, etc.–such symptoms even may occur when even a few doses of antidepressant are missed. It is recommended that the dose of antidepressant be reduced gradually when therapy is discontinued.

What is Serotonin Syndrome?

Signs and symptoms of Serotonin Syndrome include:

  • Restlessness
  • Hallucinations
  • Loss of coordination
  • Rapid heartbeat
  • Increased body temperature
  • Fast changes in blood pressure
  • Overactive reflexes
  • Diarrhea
  • Coma
  • Nausea
  • Vomiting

Serotonin Syndrome may be more likely to occur when starting or increasing the dose of an SSRI (such as Prozac) and a triptan.

Can I file a lawsuit if I have suffered damages from taking Prozac?

Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

  • Past and future medical expenses
  • Past and future pain and suffering
  • Lost wages
  • Loss of future earning capacity
  • Emotional distress

If you or a loved one has experienced any health problems while taking Prozac, you should contact your doctor immediately. You may also wish to contact an experienced Prozac lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.

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